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FDA Greenlights Veppanu for Specific Breast Cancer Type
2 May
Summary
- Veppanu pill approved for advanced estrogen receptor-positive, HER2-negative breast cancer.
- ESR1 mutation and progression after hormone therapy are required for treatment.
- Late-stage trial showed Veppanu improved progression-free survival compared to fulvestrant.
The U.S. Food and Drug Administration (FDA) granted approval on May 1, 2026, for Veppanu, a new oral medication for advanced breast cancer patients. Developed by Pfizer and Arvinas, the drug targets adults with estrogen receptor-positive, HER2-negative breast cancer that has metastasized or is inoperable. Eligibility requires the presence of an ESR1 mutation and progression of the disease after at least one prior hormone therapy.
Clinical trials indicated that Veppanu significantly improved progression-free survival compared to the existing hormone therapy, fulvestrant. The FDA's decision was supported by a late-stage study of 624 participants, which also showed higher rates of tumor shrinkage in patients treated with Veppanu. The drug's label includes warnings about potential effects on heart rhythm and risks to unborn babies.
In addition to Veppanu, the FDA also approved the Guardant360 CDx blood test to identify patients with the ESR1 mutation. Arvinas CEO Randy Teel expressed optimism, stating the approval provides a much-needed new treatment modality. The company anticipates announcing a commercialization deal soon, which will bring clarity on Veppanu's pricing. The recommended dosage is a 200 mg pill taken daily with food.
